All of 23andMe’s employees in the acquired business units will retain their jobs
One of the most consequential acquisitions in the clinical laboratory genetic testing industry is about to take place.
On May 19, Regeneron Pharmaceuticals, Inc. announced it had entered into a purchasing agreement to acquire most of the assets of 23andMe for $256 million. The acquisition, which is contingent on bankruptcy court and regulatory approvals, is expected to close during the third quarter of this year.
Once viewed as a flourishing company in the home genetics testing arena, 23andMe filed for bankruptcy in March in the Eastern District of Missouri. The latest transaction will allow Regeneron to acquire 23andMe’s Personal Genetic Service (PGS), Total Health Service and Research Service business lines, as well as its Biobank and associated assets.
The purchase will not include 23andMe’s Lemonaid Health telehealth business, which will cease operations.
“Regeneron was one of the first biotech companies to bet its future on the power of DNA, fueling our drug discovery efforts so as to deliver some of the world’s leading and most innovative medicines,” said George Yancopoulos, MD, PhD, Regeneron’s co-founder, president, and chief scientific officer in a news release.
“We believe we can help 23andMe deliver and build upon its mission to help those interested in learning about their own DNA and how to improve their personal health, while furthering Regeneron’s efforts to use large-scale genetics research to improve the way society treats and prevents illness overall,” said George Yancopoulos, MD, PhD, co-founder, president and chief scientific officer of Regeneron in a news release. (Photo copyright: New York Medical College.)
Weakening Demand, Data Breach Led to Bankruptcy
Since its founding in 2006, 23andMe has collected genetic data from more than 15 million consumers via its home DNA testing kits. It was the first company to offer autosomal DNA testing to obtain ancestry data.
Its direct-to-consumer, saliva-based genetics testing business soon gained much popularity. In 2008, Time Magazine named its Personal Genome Service “Invention of the Year.”
At its peak, the company was valued at approximately $6 billion. In its bankruptcy filing, 23andMe contended it had $277.42 million in assets and $214.7 million in outstanding debts.
Lately, 23andMe has been struggling due to a weakening demand for its ancestry testing kits. In addition, a data breach that occurred in 2023 exposed genetic data of nearly seven million customers to the offending hackers, contributing to concerns related to privacy issues.
Regeneron to Continue 23andMe’s Genomic Services
Based in Tarrytown, NY, Regeneron intends to continue uninterrupted service of 23andMe’s consumer genome services as a subsidiary business. The company asserted in its new release that it “intends to ensure compliance with 23andMe’s consumer privacy policies and applicable laws with respect to the treatment of customer data.”
The current issue of The Dark Report notes that the fate of patient DNA samples is a significant concern for 23andMe’s customers as the bankruptcy proceeds. “At least two state attorneys general, for California and Pennsylvania, have urged consumers to think critically about whether to allow their data to remain with 23andMe,” The Dark Report observed.
Regeneron has sought to reassure consumers who have used 23andMe’s services.
“Regeneron Genetics Center is committed to and has a proven track record of safeguarding the genetic data of people across the globe, and, with their consent, using this data to pursue discoveries that benefit science and society, said Aris Baras, MD, senior vice president and head of the Regeneron Genetics Center, in the news release. “We assure 23andMe customers that we are committed to protecting the 23andMe dataset with our high standards of data privacy, security and ethical oversight, and will advance its full potential to improve human health.”
Court to Review Protection of Customer Data
As part of the deal, Regeneron agreed to detail the intended use of 23andMe’s customer data, privacy programs, and security controls for review by a court-appointed, independent customer privacy ombudsman (CPO) and other interested parties.
The US Trustee Office handling the case appointed Neil Richards, JD, a law professor at Washington University School of Law as the CPO for the case. Richards will present a report to the court on June 10 outlining any potential impact on the security of 23andMe’s customer data. The acquisition is scheduled for review and potential approval on June 17.
“We are pleased to have reached a transaction that maximizes the value of the business and enables the mission of 23andMe to live on, while maintaining critical protections around customer privacy, choice and consent with respect to their genetic data,” said Mark Jensen, 23andMe’s board chair in a statement.
Regeneron will provide further details regarding its plans for customer data use as the court hearings proceed.
Unlike most other CRISPR/Cas-9 therapies that are ex vivo treatments in which cells are modified outside the body, this study was successful with an in vivo treatment
Use of CRISPR-Cas9 gene editing technology for therapeutic purposes can be a boon for clinical laboratories. Not only is this application a step forward in the march toward precision medicine, but it can give clinical labs the essential role of sequencing a patient’s DNA to help the referring physician identify how CRISPR-Cas9 can be used to edit the patient’s DNA to treat specific health conditions.
Most pathologists and medical lab managers know that CRISPR-Cas9 gene editing technology has been touted as one of the most significant advances in the development of therapies for inherited genetic diseases and other conditions. Now, a pair of biotech companies have announced a milestone for CRISPR-Cas9 with early clinical data involving a treatment delivered intravenously (in vivo).
As with other therapies, determining which patients are suitable candidates for specific treatments is key to the therapy’s success. Therefore, clinical laboratories will play a critical role in identifying those patients who would most likely benefit from a CRISPR-delivered therapy.
Such is the goal of precision medicine. As methods are refined that can correct unwelcome genetic mutations in a patient, the need to do genetic testing to identify and diagnose whether a patient has a specific gene mutation associated with a specific disease will increase.
Cleveland Clinic describes ATTR amyloidosis as a “protein misfolding disorder” involving transthyretin (TTR), a protein made in the liver. The disease leads to deposits of the protein in the heart, nerves, or other organs.
According to Intellia and Regeneron, NTLA-2001 is designed to inactivate the gene that produces the protein.
The interim clinical trial data indicated that one 0.3 mg per kilogram dose of the therapy reduced serum TTR by an average of 87% at day 28. A smaller dose of 0.1 mg per kilogram reduced TTR by an average of 52%. The researchers reported “few adverse events” in the six study patients, “and those that did occur were mild in grade.”
Current treatments, the companies stated, must be administered regularly and typically reduce TTR by about 80%.
“These are the first ever clinical data suggesting that we can precisely edit target cells within the body to treat genetic disease with a single intravenous infusion of CRISPR,” said Intellia President and CEO John Leonard, MD, in a press release. “The interim results support our belief that NTLA-2001 has the potential to halt and reverse the devastating complications of ATTR amyloidosis with a single dose.”
He added that “solving the challenge of targeted delivery of CRISPR-Cas9 to the liver, as we have with NTLA-2001, also unlocks the door to treating a wide array of other genetic diseases with our modular platform, and we intend to move quickly to advance and expand our pipeline.”
“It’s an important moment for the field,” MIT biomedical engineer Daniel Anderson, PhD (above), told Nature. Anderson is Professor, Chemical Engineering and Institute for Medical Engineering and Science at the Koch Institute for Integrative Cancer Research at MIT. “It’s a whole new era of medicine,” he added. Advances in the use of CRISPR-Cas9 for therapeutic purposes will create the need for clinical laboratories to sequence patients’ DNA to help physicians determine the best uses for a CRISPR-Cas9 treatment protocol. (Photo copyright: Massachusetts Institute of Technology.)
In Part 2 of the Phase 1 trial, Intellia plans to evaluate the new therapy at higher doses. After the trial is complete, “the company plans to move to pivotal studies for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis,” the press release states.
Previous clinical trials reported results for ex vivo treatments in which cells were removed from the body, modified with CRISPR-Cas9 techniques, and then reinfused. “But to be able to edit genes directly in the body would open the door to treating a wider range of diseases,” Nature reported.
How CRISPR-Cas9 Works
On its website, CRISPR Therapeutics, a company co-founded by Emmanuelle Charpentier, PhD, a director at the Max Planck Institute for Infection Biology in Berlin, and inventor of CRISPR-Cas9 gene editing, explained that the technology “edits genes by precisely cutting DNA and then letting natural DNA repair processes take over.” It can remove fragments of DNA responsible for causing diseases, as well as repairing damaged genes or inserting new ones.
The therapies have two components: Cas9, an enzyme that cuts the DNA, and Guide RNA (gRNA), which specifies where the DNA should be cut.
Charpentier and biochemist Jennifer Doudna, PhD, Nobel Laureate, Professor of Chemistry, Professor of Biochemistry and Molecular Biology, and Li Ka Shing Chancellor’s Professor in Biomedical and Health at the University of California Berkeley, received the 2020 Nobel Prize in Chemistry for their work on CRISPR-Cas9, STAT reported.
It is important to pathologists and medical laboratory managers to understand that multiple technologies are being advanced and improved at a remarkable pace. That includes the technologies of next-generation sequencing, use of gene-editing tools like CRISPR-Cas9, and advances in artificial intelligence, machine learning, and neural networks.
At some future point, it can be expected that these technologies will be combined and integrated in a way that allows clinical laboratories to make very early and accurate diagnoses of many health conditions.
Drugs based on knockout genes are expected to trigger the need for companion diagnostic tests that will be performed by pathologists and medical laboratory scientists
Pharmaceutical companies and other research programs are developing a new opportunity to use information from human genome sequencing to create a new class of therapeutic drugs. These drugs target “knockout genes” and those same genes are expected to be used as diagnostic biomarkers for clinical laboratory testing as a new field of companion diagnostics emerges.
In simplest terms, large-scale DNA sequencing of the human genome is enabling researchers to identify individuals with “knockout” genes and then develop therapeutic drugs based on that knowledge.
The first commercial success story from this partnership of geneticists and the pharmaceutical industry is expected to be a new class of drugs that lowers cholesterol. These drugs may reach pharmacy shelves this year, reported an October 24 Nature article. (more…)
Cloud-based genetic research networks that facilitate collaboration by stakeholders worldwide may solve the most difficult disease challenges, including a cure for cancer
Coming soon to a clinical laboratory near you: cloud-based “big data” genome analysis! A new industry is emerging dedicated to accepting, storing, and analyzing vast quantities of data generated by next-generation gene sequencing and whole human-genome sequencing.
There are already examples of academic departments of pathology and laboratory medicine that have outsourced the storage and annotation of whole human genomes sequenced from tissue specimens collected from cancer patients. The annotated genomes are returned to the referring pathologists for analysis. (more…)
